Abstract:
Introduction: The inclusion of a patient information leaflet (PIL) in medicine packaging is a legal requirement in most countries and ensures the patient has the latest product information. The advancement in technology has led to many countries implementing electronic patient information leaflets (ePILs) via quick response (QR) codes on medicine packaging. This study aimed to assess the feasibility of QR codes for patient information delivery.
Method: A mixed method involving two cross sectional surveys carried out amongst 333 patients as well as 17 pharmacists and pharmacists’ assistants at Tshwane District Hospital and one focus group study amongst 18 regulatory affairs pharmacists. Ethics approval was received from the University of Pretoria Faculty of Health Sciences, Research Ethics Committee (444/2022). Patients older than 18 years who speak English as a primary or secondary language were included in the study.
Results: The majority of patients were willing (85%), and able (80%) to scan the QR code presented to them. Among the patients who scanned the QR code, over 96% found it easier to read the ePIL (C=0.487, p <0.001) and locate the information they needed (C=0.521, p <0.001). Patients reported a positive sentiment towards the ePIL with 80% of the population preferring either the ePIL (35%) or ePIL with a hardcopy (45%). Pharmacists and pharmacist assistants, 56% were willing and able to scan the QR code, whereas 69% preferred the provision of the ePIL with a hardcopy. Of the pharmacists and pharmacist assistants who scanned the QR code, 89% found it easy to read the ePIL (C=0.746, p <0.05), 78% confirmed they could locate the information on the ePIL (C=0.630, p <0.05) and would utilise the ePIL to counsel patients. All the regulatory affairs pharmacists in the focus group preferred the ePIL and indicated that it was an easy process to create a QR code for an ePIL.
Conclusion: Despite the positive sentiment toward the inclusion of the ePIL, neither patients nor pharmacy staff are ready to fully transition to ePIL only format. They preferred a dual system including both a QR coded PIL and hardcopy PIL. In contrast regulatory affairs pharmacists advocated for ePILs only given the efficiency of managing safety updates on PILs.